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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM); FARASTAR™ Recording System Modul
Generic NamePercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
ApplicantFarapulse, Inc.
3715 Haven Ave.
Suite 110
Menlo Park, CA 94025
PMA NumberP230030
Supplement NumberS024
Date Received06/30/2026
Decision Date09/04/2026
Product Code QZI 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for FARASTAR PFA Generator Software 4.5.3/4.6.3, FARASTAR Foot Switch, and updates to the FARASTAR System Instructions for Use
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